Auditing in middle ear surgery, feasibility of the common otology database

Clinical auditing is a systematic process for improving quality of care. The primary goal is to compare current practice with established standards. A common dataset enables the comparison of results, and takes into account the effect of case mix, surgical techniques and follow-up periods on outcome. The Common Otology Database (COD) is a joint effort of an international group of otologists to standardise reporting on middle ear surgery, including myringoplasty, ossiculoplasty, stapes surgery and cholesteatoma removal. It aims to identify audit data using the internet (http://www.ear-audit.net), provide a storage system for otological data, to create a prospective database allowing statistical analysis with sufficient power and to produce standards for comparative auditing.

The COD provides two levels of data entry, anonymising surgeon and patient data. Level 1 is designed for general otorhinolaryngologists and trainees, and only records main outcomes. Level 2 is designed for benchmark otologists and includes detailed information about pathologies, risk factors, aim of surgery, surgical findings, procedures, follow-up periods and complications. Level-2 surgeons are required to submit pre-operative data on all patients scheduled for surgery in order to eliminate bias as a result of selective reporting.

The COD began in January 2004 and is continuously including patients. In May 2009, 2,291 cases were entered in the level-2 benchmark database, including 1,218 myringoplasties (53.2%), 576 ossiculoplasties (25.1%), 695 stapes surgeries (30.3%) and 532 cholesteatoma surgeries (23.2%). Currently, 151 surgeons use the database system (levels 1 and 2 combined). Eighteen otologists were invited to contribute to the level 2 database. Eight contributors complied with the validation criteria. Others did not cooperate, citing a lack of resources to support data input, or their health system discouraging follow-up. Some were also reluctant to have their outcome data subjected to external validation.

The COD has engaged the otological community to participate in a large-scale audit of current practice. The number of surgical procedures included has attained a level of power that will allow introductory statistical analysis.